Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 47
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.
详细描述
This is a randomized open label multicenter comparative phase II trial. The objective of the study is to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after resection and radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Trabectedin
Patient will be treated with trabectedin
干预措施: Trabectedin (Drug)
Local standard of care
Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care.
干预措施: Local standard of care (Other)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first up.PFS was assessed by its median the point time at which 50% of the patients have experienced disease progression or death.
Progression (PD) was measured according to the Macdonald response criteria as at least a 25% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥ 5 mm. Appearance of new lesions will also constitute PD (including lesions in previously unassessed areas). Progression Free Survival (PFS) was measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. Patients without evidence of progression was censored at the last follow-up visit date. If a patient received a second anti-tumoral therapy without prior documentation of disease progression, the patient was censored at the date of starting new anti-tumoral therapy.
次要结局
- Progression Free Survival at 6 Months (PFS-6)(From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. PFS at 6 months,the proportion of patients who have not experienced disease progression or death by 6 months is presented)
- Objective Response (CR/PR)(From the date of randomization until disease progression or death, up to 24 months from date of randomization.It was assessed every 9 or 12 weeks (see measure description for details).The response rate presented is based on the best response observed.)
- Overall Survival (OS)(From the date of randomization up to the date of death. OS was assessed by its median the point time at which 50% of the patients have experienced death.)
- Health-related Quality of Life (HRQol)(Baseline measurements were collected before or on the day of the start of protocol treatment, but no earlier than 28 days before. The median baseline Global health status / QoL scores per treatment arm is reported.)